NCT02468336

Brief Summary

The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2015

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

June 7, 2015

Last Update Submit

January 31, 2018

Conditions

Cardiovascular Diseases

Keywords

Physiology

Outcome Measures

Primary Outcomes (1)

  • Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)

    Deming regression analysis and Bland-Altman Plots

    1 day

Secondary Outcomes (1)

  • Comparison of types and incidences of emergent adverse device effects

    1 day

Study Arms (2)

AngioDefender

EXPERIMENTAL

The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after BA occlusion by a standard upper arm sphygmomanometric blood pressure (BP) cuff. The procedure is non-invasive and employs neither ultrasound nor Doppler flow analysis.

Device: AngioDefender

Brachial Artery Ultrasound Imaging

ACTIVE COMPARATOR

A non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery (BA) using high resolution continuous ECG-gated B-mode (2D) ultrasound imaging during reactive hyperemia, a state of transient increase in tissue blood flow that occurs following a brief period of ischemia, e.g., BA occlusion. BA diameter is measured at end-diastole, coincident with the R wave of a simultaneously recorded ECG.

Device: Ultrasound

Interventions

AngioDefenderDEVICE
AngioDefender
UltrasoundDEVICE
Brachial Artery Ultrasound Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG 0-2

You may not qualify if:

  • Body mass index (BMI) \>50 kg/m2
  • Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>40 cm
  • Sinus arrhythmia (RR intervals vary by \>50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
  • Clinical signs and/or symptoms of active viral or bacterial infections
  • Resting tremor or inability to remain still for the duration of AD and BAUI testing
  • Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
  • Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado, Boulder

Boulder, Colorado, 80303, United States

Location

Yale University Prevention Research Center

Derby, Connecticut, 06418, United States

Location

Boston University

Boston, Massachusetts, 02118, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Peter F Lenehan, MD PhD

    Everist Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2015

First Posted

June 10, 2015

Study Start

August 1, 2015

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(4)